(58 days)
Non-Woven sponge for wound dressing prepping and scrubbing.
Non-Woven Sponge, Sterile
I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a Non-Woven Sponge, indicating that the device is substantially equivalent to legally marketed predicate devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter focuses on the regulatory clearance process and does not delve into the detailed technical or clinical studies that might be associated with evaluating the device's performance against specific criteria.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.